Job Description

Kelly Science & Clinical is seeking a Senior Manager – Technical Operations near Northbrook, IL.

Direct Hire

Shift: Monday – Friday 8am-5pm

Compensation and Benefits:

Salary range: $92,891 - $165,000 annually.

Compensation will be based on education, skills, experience, certifications, and other factors. Comprehensive benefits package offered, including health coverage, retirement plans, wellness programs, time off, and potential annual incentives based on organizational and individual performance. Benefits may vary depending on role, location, and employment status.

Position Overview:

The Senior Manager, Technical Operations leads a team responsible for Design Transfer, ensuring Design for Manufacturability, and resolving technical issues related to product design transition, process development, and process validations. This role serves as a key liaison between R&D and manufacturing, managing product design transfer projects and supporting process optimization and validation activities.

Job Scope:

• Oversee product design transfer projects from Research & Development (R&D) to manufacturing, ensuring the seamless transition of new products and processes.
• Act as an operations representative on design and new product development teams to ensure robust, manufacturable products and stable technology transfers.
• Support manufacturing operations in problem-solving related to products, systems, designs, processes, equipment, and scale-up.
• Provide technical support to external manufacturers, customers, and key partners as required.
• Lead and manage key strategic projects, working with internal and external resources to achieve project milestones.
• Support process development, optimization, and validation initiatives.

Key Duties and Responsibilities:

• Lead assay design transfer from R&D to Manufacturing, focusing on the design and implementation of new products, processes, procedures, and specifications.
• Collaborate with R&D, Manufacturing, and Quality teams on product scale-up, process optimization, technology transfer, and process validation activities.
• Develop and maintain detailed project schedules, managing all phases of the design transfer process.
• Support Corrective and Preventive Action (CAPA) implementation and drive process improvement initiatives.
• Assist quality and regulatory departments in the preparation, conduct, and response to internal and external audits.
• Participate in laboratory assay validations and troubleshooting laboratory activities as needed.
• Ensure ongoing compliance with ISO 9001/EN 46001 and ISO 13485 standards.
• Analyze and interpret data, identifying issues and making decisions regarding the insourcing or outsourcing of products and processes.
• Contribute to the development of annual budgets by providing required operational input.
• Mentor and develop team members into independent investigators.
• Supervise a team of 2-4 process scientists.
• Perform additional duties as assigned.

Education, Experience, and Qualifications:

• Ph.D. or Master's degree in a biomedical-related discipline.
• Minimum 5 years of experience in Technical Operations, Design Transfer, Product Development, or related fields.
• At least 5 years of experience working in a regulated environment with GMP in IVD, medical device, or a similar industry.
• Strong molecular biology expertise, including PCR, qPCR, multiplexed PCR, and NGS technologies.
• Minimum of 2–3 years in a supervisory or management role.
• Proven experience in molecular assay design transfer from R&D to manufacturing.
• Expert knowledge of laboratory and manufacturing equipment and processes for molecular medical devices.
• Demonstrated ability to diagnose problems, resolve key technical issues, and implement effective solutions.
• Experience in validation planning and execution, including risk-based validation approaches.
• Excellent communication, leadership, organizational, and presentation skills.
• Ability to manage multiple projects in a fast-paced environment and function as an effective team player.

Travel Requirements:

• Up to 10% infrequent travel may be required.

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